1. New Meeting Time: Discussed moving the time of the meeting to 1 pm to be more convenient for West Coast callers. Meetings would be held on opposite days from the SPL Process Team meetings. Next meeting will be held on Sept 24th at 1pm Easter Time.
2. Training Opportunities: Upcoming DIA Meetings: Structured Product Labeling (SPL): Preparing for FDA Electronic Drug Registration and Drug Listing
October 29 - 30 | Philadelphia, PA
3. DIA Webinar Update: Several people attended the DIA Webinar. Slides were made available. We are checking to see if we can post on the WIKI.
4. Feedback on WIKI website:
A group of people from the SPL Process team have been updating a website as a reference point for all of the SPL changes. The WIKI has been updated and a few people have accessed it to find information. Feedback on the WIKI suggests that it is somewhat difficult to navigate but loaded with information. It will be a valuable resource for all needing information on Drug Listing and Establishment registration as well as SPL 4. Several scenarios will also be posted to help people find situations similar to theirs that will help them prepare SPL v. 4.
5. DUNS issues: Several people have started setting up drug listing for their products. There are several fundamental issues with gathering information for the drug listing. The biggest issue has been the DUNS number. Information has been inaccurate and correcting this information has been a challenge. We would like to set up of a meeting with D&B to discuss some of the issues and have FDA present at the meeting. D&B will be contacted and a meeting will be scheduled.
6. Training session with FDA
A training session with FDA is open for those who would like to participate. A webinar will be set up between organizations and FDA and will walk through their actual process to find any kinks along the way. Case Studies will be created based on these sessions (sponsors can change the information to keep it confidential) and these will be posted on the WIKI for informational purposes. Any volunteers can contact either me or spl@fda.hhs.gov. A few individuals have already contacted FDA to set up a meeting.
7. Next meeting will be on Sept. 24, 2008 at 1 pm EDST.
1. New Meeting Time:
Discussed moving the time of the meeting to 1 pm to be more convenient for West Coast callers. Meetings would be held on opposite days from the SPL Process Team meetings. Next meeting will be held on Sept 24th at 1pm Easter Time.
2. Training Opportunities:
Upcoming DIA Meetings:
Structured Product Labeling (SPL): Preparing for FDA Electronic Drug Registration and Drug Listing
October 29 - 30 | Philadelphia, PA
3. DIA Webinar Update:
Several people attended the DIA Webinar. Slides were made available. We are checking to see if we can post on the WIKI.
4. Feedback on WIKI website:
A group of people from the SPL Process team have been updating a website as a reference point for all of the SPL changes. The WIKI has been updated and a few people have accessed it to find information. Feedback on the WIKI suggests that it is somewhat difficult to navigate but loaded with information. It will be a valuable resource for all needing information on Drug Listing and Establishment registration as well as SPL 4. Several scenarios will also be posted to help people find situations similar to theirs that will help them prepare SPL v. 4.
5. DUNS issues:
Several people have started setting up drug listing for their products. There are several fundamental issues with gathering information for the drug listing. The biggest issue has been the DUNS number. Information has been inaccurate and correcting this information has been a challenge. We would like to set up of a meeting with D&B to discuss some of the issues and have FDA present at the meeting. D&B will be contacted and a meeting will be scheduled.
6. Training session with FDA
A training session with FDA is open for those who would like to participate. A webinar will be set up between organizations and FDA and will walk through their actual process to find any kinks along the way. Case Studies will be created based on these sessions (sponsors can change the information to keep it confidential) and these will be posted on the WIKI for informational purposes. Any volunteers can contact either me or spl@fda.hhs.gov. A few individuals have already contacted FDA to set up a meeting.
7. Next meeting will be on Sept. 24, 2008 at 1 pm EDST.